Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety

NCT05852886 | Completed FDA Device

• 1 other identifier: 22-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end. EOHS is intended for a caregiver to use to remove adherent plaque and food debris from the teeth of a consumer to reduce tooth decay. Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety is a first-in-human-use single arm clinical study to evaluate the safety of EOHS. This study has been designed to assess the safety of the device during self-brushing. The primary objective of the study is to evaluate the safety of the EOHS with able-bodied individuals during self-brushing. The primary endpoint for safety is 28 days. The primary endpoint of the study will be met if there are no device failures and no Adverse Device Effects (ADEs). Subjective assessment of cleaning using the EHOS during self-brushing will also be evaluated. A total of up to 12 subjects will be enrolled in the study.

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events related to toothbrush use.

  Incidence of adverse events related to toothbrush use.

  28 days

• Incidence of device failure.

  Incidence of device failure.

  28 days

Secondary Outcomes (1)

• Perception of cleanliness following use of the experimental toothbrush based on a Likert scale.

  28 days

Study Arms (1)

Toothbrush

EXPERIMENTAL

Use of experimental toothbrush for 28 days.

Device: Enable Oral Hygiene System (EOHS)

Interventions

Enable Oral Hygiene System (EOHS) DEVICE

The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end.

Toothbrush

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to attempt brushing 2 x daily.
• Write and read English.
• years of age.

You may not qualify if:

• Individuals who identify as a dentist, dental student, or a dental professional.
• Any physical limitations that might compromise normal tooth brushing technique.
• Teeth with orthodontic appliances.
• Evidence of periodontal abscess or major hard or soft tissue lesions or trauma.
• Use of anti-inflammatory medications for three or more consecutive days in the previous 28 days.
• Not willing to comply.

Sponsors & Collaborators

• Center for Disability Services, New York: lead
• Tufts University School of Dental Medicine: collaborator

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 021111, United States

Location

Study Officials

• Adam Lowenstein, MS, DMD

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First-in-human-use single arm clinical study to evaluate safety.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 10, 2023
• Study Start: March 27, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)